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CAndesartan vs LIsinopril Effects on the BRain (CALIBREX)

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ClinicalTrials.gov Identifier: NCT01984164
Recruitment Status : Completed
First Posted : November 14, 2013
Results First Posted : February 21, 2021
Last Update Posted : February 21, 2021
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Ihab Hajjar, Emory University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Conditions Hypertension
Mild Cognitive Impairment
Interventions Drug: Candesartan
Drug: Lisinopril
Enrollment 176
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Candesartan Lisinopril
Hide Arm/Group Description

To achieve blood pressure control, we will use a stepwise protocol as follows: candesartan (blinded) 8mg→ 16mg→ 32mg. Both groups will also receive (unblinded) , if needed to achieve blood pressure control, HCTZ 12.5mg→ 25mg, Amlodipine 2.5mg→ 5mg →10mg and metoprolol succinate extended release 12.5mg→ 25mg→ 50mg. Antihypertensive medications will be increased every 2 weeks until control is achieved.

Candesartan: blinded

To achieve blood pressure control we will use a stepwise protocol as follows: lisinopril (blinded) 10mg→ 20mg→ 40mg. Both groups will also receive (unblinded), if needed to achieve blood pressure control, HCTZ 12.5mg→ 25mg, Amlodipine 2.5mg→ 5mg→ 10mg and metoprolol succinate extended release 12.5mg→ 25mg→ 50mg. Antihypertensive medications will be increased every 2 weeks until control is achieved.

Lisinopril: Blinded

Period Title: Overall Study
Started 87 89
Completed 77 64
Not Completed 10 25
Reason Not Completed
Withdrawal by Subject             4             3
Adverse Event             5             19
Lost to Follow-up             1             3
Arm/Group Title Candesartan Lisinopril Total
Hide Arm/Group Description

To achieve blood pressure control, we will use a stepwise protocol as follows: candesartan (blinded) 8mg→ 16mg→ 32mg. Both groups will also receive (unblinded) , if needed to achieve blood pressure control, HCTZ 12.5mg→ 25mg, Amlodipine 2.5mg→ 5mg →10mg and metoprolol succinate extended release 12.5mg→ 25mg→ 50mg. Antihypertensive medications will be increased every 2 weeks until control is achieved.

Candesartan: blinded

To achieve blood pressure control we will use a stepwise protocol as follows: lisinopril (blinded) 10mg→ 20mg→ 40mg. Both groups will also receive (unblinded), if needed to achieve blood pressure control, HCTZ 12.5mg→ 25mg, Amlodipine 2.5mg→ 5mg→ 10mg and metoprolol succinate extended release 12.5mg→ 25mg→ 50mg. Antihypertensive medications will be increased every 2 weeks until control is achieved.

Lisinopril: Blinded

Total of all reporting groups
Overall Number of Baseline Participants 87 89 176
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 87 participants 89 participants 176 participants
66.1  (8.3) 65.8  (7.2) 65.9  (8.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 87 participants 89 participants 176 participants
Female
47
  54.0%
54
  60.7%
101
  57.4%
Male
40
  46.0%
35
  39.3%
75
  42.6%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 87 participants 89 participants 176 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
56
  64.4%
57
  64.0%
113
  64.2%
White
29
  33.3%
31
  34.8%
60
  34.1%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
2
   2.3%
1
   1.1%
3
   1.7%
Region of Enrollment   [1] 
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 87 participants 89 participants 176 participants
87 89 176
[1]
Measure Description: Of 176 eligible participants enrolled and randomized to candesartan or lisinopril, 35 dropped out before study completion (25 from the lisinopril arm and 10 from the candesartan arm). The final sample for the intention-to-treat analysis was 141 individuals, including 77 in the candesartan group and 64 in the lisinopril group.
MoCA score   [1] 
Mean (Standard Deviation)
Unit of measure:  Points
Number Analyzed 87 participants 89 participants 176 participants
21.4  (3.4) 21.7  (3.5) 21.5  (3.4)
[1]
Measure Description: MoCA is a 30-point scale administered in 10 minutes, is validated in Spanish and is highly sensitive to identify mild vascular-related cognitive dysfunction. MoCA includes assessment of MoCA assesses: Short term memory, visuospatial abilities, executive functions, attention, concentration and working memory, language and orientation to time and place. Scale is 0-30 with higher indicated better cognitive performance.
1.Primary Outcome
Title Executive Function
Hide Description Executive function will be assessed using Trail Making Test (part B-A). Part A was collected to correct for motor speed and visual-perceptual demands on TMT by subtracting completion time for TMT Part A from completion time for Part B (TMT B - A). TMT Part B-A provides a relatively purer measure of executive functioning. It has a timed scale from 0 sec (min) to 300 secs (max). Along this scale, a lower score is better.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Candesartan Lisinopril
Hide Arm/Group Description:

To achieve blood pressure control, we will use a stepwise protocol as follows: candesartan (blinded) 8mg→ 16mg→ 32mg. Both groups will also receive (unblinded) , if needed to achieve blood pressure control, HCTZ 12.5mg→ 25mg, Amlodipine 2.5mg→ 5mg →10mg and metoprolol succinate extended release 12.5mg→ 25mg→ 50mg. Antihypertensive medications will be increased every 2 weeks until control is achieved.

Candesartan: blinded

To achieve blood pressure control we will use a stepwise protocol as follows: lisinopril (blinded) 10mg→ 20mg→ 40mg. Both groups will also receive (unblinded), if needed to achieve blood pressure control, HCTZ 12.5mg→ 25mg, Amlodipine 2.5mg→ 5mg→ 10mg and metoprolol succinate extended release 12.5mg→ 25mg→ 50mg. Antihypertensive medications will be increased every 2 weeks until control is achieved.

Lisinopril: Blinded

Overall Number of Participants Analyzed 87 89
Least Squares Mean (Standard Error)
Unit of Measure: seconds
87.23  (5.46) 111.37  (5.89)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Candesartan, Lisinopril
Comments All analyses were conducted using the intention-to-treat principle. Results are provided as adjusted least-square means with SE and effect size (ES) estimates (calculated from mixed model with repeated measures (MMRM) as the adjusted difference in cognitive change between the 2 groups over the study period).
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Treatment effect size
Estimated Value -13.6
Confidence Interval (2-Sided) 95%
-23.6 to -3.7
Estimation Comments effect size p-value = 0.008
2.Primary Outcome
Title NINDS-initiated EXecutive Abilities: Measures and Instruments for Neurobehavioral Evaluation and Research or "EXAMINER" Tool Box.
Hide Description EXecutive Abilities: Measures and Instruments for Neurobehavioral Evaluation and Research or "EXAMINER" tool box. This test batteryThe battery includes 11 tasks that generate 15 primary variables. Within this set, the EXAMINER includes: working memory, inhibition, set shifting, and fluency. The parts of EXAMINER that were used for this study include: Flanker task (inhibition) which involves responding to a central stimulus while ignoring flanking stimuli that are either compatible or incompatible with the central stimulus; Set-shifting, a measure of mental flexibility; Spatial 1-Back test assesses spatial working memory; Dot Counting test assesses verbal working memory; Verbal Fluency tested using a List Generation test which require the participant to generate words beginning with a specific letter, and category fluency in which the participant generates words from a specified category (e.g., animals, fruits). Higher are reflective of better executive function (-1 to +1)
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Candesartan Lisinopril
Hide Arm/Group Description:

To achieve blood pressure control, we will use a stepwise protocol as follows: candesartan (blinded) 8mg→ 16mg→ 32mg. Both groups will also receive (unblinded) , if needed to achieve blood pressure control, HCTZ 12.5mg→ 25mg, Amlodipine 2.5mg→ 5mg →10mg and metoprolol succinate extended release 12.5mg→ 25mg→ 50mg. Antihypertensive medications will be increased every 2 weeks until control is achieved.

Candesartan: blinded

To achieve blood pressure control we will use a stepwise protocol as follows: lisinopril (blinded) 10mg→ 20mg→ 40mg. Both groups will also receive (unblinded), if needed to achieve blood pressure control, HCTZ 12.5mg→ 25mg, Amlodipine 2.5mg→ 5mg→ 10mg and metoprolol succinate extended release 12.5mg→ 25mg→ 50mg. Antihypertensive medications will be increased every 2 weeks until control is achieved.

Lisinopril: Blinded

Overall Number of Participants Analyzed 87 89
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
0.07  (0.07) 0.25  (0.07)
3.Secondary Outcome
Title Memory
Hide Description To assess episodic memory, the Hopkins Verbal Learning Test-Revised (HVLT-R) will be used. The retention (%) score is calculated by dividing the delayed recall trial by the higher of 3 learning trials. Each trial scores 0 (min) to 12 (max). The HVLT-R retention score is a percentage, and a higher percentage represents a better outcome.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Candesartan Lisinopril
Hide Arm/Group Description:

To achieve blood pressure control, we will use a stepwise protocol as follows: candesartan (blinded) 8mg→ 16mg→ 32mg. Both groups will also receive (unblinded) , if needed to achieve blood pressure control, HCTZ 12.5mg→ 25mg, Amlodipine 2.5mg→ 5mg →10mg and metoprolol succinate extended release 12.5mg→ 25mg→ 50mg. Antihypertensive medications will be increased every 2 weeks until control is achieved.

Candesartan: blinded

To achieve blood pressure control we will use a stepwise protocol as follows: lisinopril (blinded) 10mg→ 20mg→ 40mg. Both groups will also receive (unblinded), if needed to achieve blood pressure control, HCTZ 12.5mg→ 25mg, Amlodipine 2.5mg→ 5mg→ 10mg and metoprolol succinate extended release 12.5mg→ 25mg→ 50mg. Antihypertensive medications will be increased every 2 weeks until control is achieved.

Lisinopril: Blinded

Overall Number of Participants Analyzed 87 89
Least Squares Mean (Standard Error)
Unit of Measure: percentage of retention
82.71  (3.26) 79.47  (3.39)
4.Secondary Outcome
Title Language
Hide Description This will be measured using the Boston Naming Test. BNT is a neuropsychological test used to assess visual confrontation naming and language performance in participants with cognitive decline. Its short 15-item version consists of drawings of objects ranging from common objects to less familiar objects. Scale: 0 (min score) to 15 (max score). For this test, a higher score/response represents a better outcome.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Candesartan Lisinopril
Hide Arm/Group Description:

To achieve blood pressure control, we will use a stepwise protocol as follows: candesartan (blinded) 8mg→ 16mg→ 32mg. Both groups will also receive (unblinded) , if needed to achieve blood pressure control, HCTZ 12.5mg→ 25mg, Amlodipine 2.5mg→ 5mg →10mg and metoprolol succinate extended release 12.5mg→ 25mg→ 50mg. Antihypertensive medications will be increased every 2 weeks until control is achieved.

Candesartan: blinded

To achieve blood pressure control we will use a stepwise protocol as follows: lisinopril (blinded) 10mg→ 20mg→ 40mg. Both groups will also receive (unblinded), if needed to achieve blood pressure control, HCTZ 12.5mg→ 25mg, Amlodipine 2.5mg→ 5mg→ 10mg and metoprolol succinate extended release 12.5mg→ 25mg→ 50mg. Antihypertensive medications will be increased every 2 weeks until control is achieved.

Lisinopril: Blinded

Overall Number of Participants Analyzed 87 89
Least Squares Mean (Standard Error)
Unit of Measure: number of correct responses
13.42  (0.18) 13.84  (0.18)
5.Secondary Outcome
Title Attention Measured Using Digit Span Backward
Hide Description The Digit Span test is a subtest of both the Wechsler Adult Intelligence Scale (WAIS) and the Wechsler Memory Scales (WMS). For the digit span backwards, subjects are read a sequence of numbers and asked to repeat the same sequence back to the examiner in reverse order (backward span). Backward span is an executive task particularly dependent on working memory. The Digit Span backward is scored for backwards performance. Scale: 0 (minimum) to 16 (maximum). A higher score represents a better outcome.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Candesartan Lisinopril
Hide Arm/Group Description:

To achieve blood pressure control, we will use a stepwise protocol as follows: candesartan (blinded) 8mg→ 16mg→ 32mg. Both groups will also receive (unblinded) , if needed to achieve blood pressure control, HCTZ 12.5mg→ 25mg, Amlodipine 2.5mg→ 5mg →10mg and metoprolol succinate extended release 12.5mg→ 25mg→ 50mg. Antihypertensive medications will be increased every 2 weeks until control is achieved.

Candesartan: blinded

To achieve blood pressure control we will use a stepwise protocol as follows: lisinopril (blinded) 10mg→ 20mg→ 40mg. Both groups will also receive (unblinded), if needed to achieve blood pressure control, HCTZ 12.5mg→ 25mg, Amlodipine 2.5mg→ 5mg→ 10mg and metoprolol succinate extended release 12.5mg→ 25mg→ 50mg. Antihypertensive medications will be increased every 2 weeks until control is achieved.

Lisinopril: Blinded

Overall Number of Participants Analyzed 87 89
Least Squares Mean (Standard Error)
Unit of Measure: Number of correct responses
5.14  (0.25) 5.16  (0.26)
6.Secondary Outcome
Title White Matter Lesion Volume
Hide Description White Matter Lesion volume: high-resolution anatomical images are acquired for the measurement of microvascular disease. WMH volumes will be obtained from Fluid attenuated inversion recovery (FLAIR) imaging sequence and reported as total volume (in mm3). Higher values means greater WMH
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Of 176 randomized participants, 27 did not complete an MRI scan at baseline (15 had metal implants with either pacemaker, stent, or inferior vena cava filter and 12 were claustrophobic). Of 141 participants who returned for their 12-month visit, an additional 8 participants refused to have a follow-up MRI. The final sample with both baseline and 12-month MRI was 104 participants (73.8%), including 51 participants in the candesartan group and 53 participants in the lisinopril group.
Arm/Group Title Candesartan Lisinopril
Hide Arm/Group Description:

To achieve blood pressure control, we will use a stepwise protocol as follows: candesartan (blinded) 8mg→ 16mg→ 32mg. Both groups will also receive (unblinded) , if needed to achieve blood pressure control, HCTZ 12.5mg→ 25mg, Amlodipine 2.5mg→ 5mg →10mg and metoprolol succinate extended release 12.5mg→ 25mg→ 50mg. Antihypertensive medications will be increased every 2 weeks until control is achieved.

Candesartan: blinded

To achieve blood pressure control we will use a stepwise protocol as follows: lisinopril (blinded) 10mg→ 20mg→ 40mg. Both groups will also receive (unblinded), if needed to achieve blood pressure control, HCTZ 12.5mg→ 25mg, Amlodipine 2.5mg→ 5mg→ 10mg and metoprolol succinate extended release 12.5mg→ 25mg→ 50mg. Antihypertensive medications will be increased every 2 weeks until control is achieved.

Lisinopril: Blinded

Overall Number of Participants Analyzed 51 53
Least Squares Mean (Standard Error)
Unit of Measure: mm^3
2.68  (1.23) 5.73  (1.22)
7.Secondary Outcome
Title Cerebral Perfusion
Hide Description ASL-MRI: Arterial Spin Labeling (ASL) MRI is non-invasive measure of perfusion that does not require contrast, and allows multiple brain regions mapping of perfusion and reserve. ASL-MRI provides measures of cerebral blood flow (CBF). Higher values indicates higher CBF.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Of 176 randomized participants, 27 did not complete an MRI scan at baseline (15 had metal implants with either pacemaker, stent, or inferior vena cava filter and 12 were claustrophobic). Of 141 participants who returned for their 12-month visit, an additional 8 participants refused to have a follow-up MRI. The final sample with both baseline and 12-month MRI was 104 participants (73.8%), including 51 participants in the candesartan group and 53 participants in the lisinopril group.
Arm/Group Title Candesartan Lisinopril
Hide Arm/Group Description:

To achieve blood pressure control, we will use a stepwise protocol as follows: candesartan (blinded) 8mg→ 16mg→ 32mg. Both groups will also receive (unblinded) , if needed to achieve blood pressure control, HCTZ 12.5mg→ 25mg, Amlodipine 2.5mg→ 5mg →10mg and metoprolol succinate extended release 12.5mg→ 25mg→ 50mg. Antihypertensive medications will be increased every 2 weeks until control is achieved.

Candesartan: blinded

To achieve blood pressure control we will use a stepwise protocol as follows: lisinopril (blinded) 10mg→ 20mg→ 40mg. Both groups will also receive (unblinded), if needed to achieve blood pressure control, HCTZ 12.5mg→ 25mg, Amlodipine 2.5mg→ 5mg→ 10mg and metoprolol succinate extended release 12.5mg→ 25mg→ 50mg. Antihypertensive medications will be increased every 2 weeks until control is achieved.

Lisinopril: Blinded

Overall Number of Participants Analyzed 51 53
Least Squares Mean (Standard Error)
Unit of Measure: ml/100g/min
45.48  (1.47) 47.65  (1.08)
8.Secondary Outcome
Title Attention Measured Using Digit Span Forward
Hide Description This will be measured using Digit Span Forward. The Digit Span test is a subtest of both the Wechsler Adult Intelligence Scale (WAIS) and the Wechsler Memory Scales (WMS). For the digit span forward, subjects are read a sequence of numbers and asked to repeat the same sequence back to the examiner in the correct order (forward span). Forward span captures attention efficiency and capacity. The Digit Span forward is scored for forwards performance. Scale: 0 (minimum) to 16 (maximum). A higher score represents a better outcome.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Candesartan Lisinopril
Hide Arm/Group Description:

To achieve blood pressure control, we will use a stepwise protocol as follows: candesartan (blinded) 8mg→ 16mg→ 32mg. Both groups will also receive (unblinded) , if needed to achieve blood pressure control, HCTZ 12.5mg→ 25mg, Amlodipine 2.5mg→ 5mg →10mg and metoprolol succinate extended release 12.5mg→ 25mg→ 50mg. Antihypertensive medications will be increased every 2 weeks until control is achieved.

Candesartan: blinded

To achieve blood pressure control we will use a stepwise protocol as follows: lisinopril (blinded) 10mg→ 20mg→ 40mg. Both groups will also receive (unblinded), if needed to achieve blood pressure control, HCTZ 12.5mg→ 25mg, Amlodipine 2.5mg→ 5mg→ 10mg and metoprolol succinate extended release 12.5mg→ 25mg→ 50mg. Antihypertensive medications will be increased every 2 weeks until control is achieved.

Lisinopril: Blinded

Overall Number of Participants Analyzed 87 89
Least Squares Mean (Standard Error)
Unit of Measure: Number of correct responses
9.67  (0.61) 8.93  (0.66)
Time Frame 12 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Candesartan Lisinopril
Hide Arm/Group Description

To achieve blood pressure control, we will use a stepwise protocol as follows: candesartan (blinded) 8mg→ 16mg→ 32mg. Both groups will also receive (unblinded) , if needed to achieve blood pressure control, HCTZ 12.5mg→ 25mg, Amlodipine 2.5mg→ 5mg →10mg and metoprolol succinate extended release 12.5mg→ 25mg→ 50mg. Antihypertensive medications will be increased every 2 weeks until control is achieved.

Candesartan: blinded

To achieve blood pressure control we will use a stepwise protocol as follows: lisinopril (blinded) 10mg→ 20mg→ 40mg. Both groups will also receive (unblinded), if needed to achieve blood pressure control, HCTZ 12.5mg→ 25mg, Amlodipine 2.5mg→ 5mg→ 10mg and metoprolol succinate extended release 12.5mg→ 25mg→ 50mg. Antihypertensive medications will be increased every 2 weeks until control is achieved.

Lisinopril: Blinded

All-Cause Mortality
Candesartan Lisinopril
Affected / at Risk (%) Affected / at Risk (%)
Total   0/87 (0.00%)      0/89 (0.00%)    
Hide Serious Adverse Events
Candesartan Lisinopril
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/87 (0.00%)      0/89 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Candesartan Lisinopril
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   87/87 (100.00%)      89/89 (100.00%)    
Blood and lymphatic system disorders     
Unusual bleeding or bruising *  0/87 (0.00%)  0 1/89 (1.12%)  1
Cardiac disorders     
Palpitation *  4/87 (4.60%)  4 4/89 (4.49%)  4
Gastrointestinal disorders     
Flatulence *  0/87 (0.00%)  0 1/89 (1.12%)  1
Loss of appetite *  0/87 (0.00%)  0 1/89 (1.12%)  1
Nausea *  2/87 (2.30%)  2 1/89 (1.12%)  1
General disorders     
Headache *  18/87 (20.69%)  18 22/89 (24.72%)  22
Dizziness *  15/87 (17.24%)  15 14/89 (15.73%)  14
Edema *  13/87 (14.94%)  13 12/89 (13.48%)  12
General Pain *  7/87 (8.05%)  7 9/89 (10.11%)  9
Fatigue *  9/87 (10.34%)  9 7/89 (7.87%)  7
Insomnia *  0/87 (0.00%)  0 2/89 (2.25%)  2
Falling *  3/87 (3.45%)  3 1/89 (1.12%)  1
Dry mouth *  1/87 (1.15%)  1 1/89 (1.12%)  1
Sweating *  0/87 (0.00%)  0 1/89 (1.12%)  1
Fainting *  1/87 (1.15%)  1 0/89 (0.00%)  0
Metabolism and nutrition disorders     
Low potassium (<3.0) *  2/87 (2.30%)  2 0/89 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Leg Cramps *  1/87 (1.15%)  1 2/89 (2.25%)  2
Renal and urinary disorders     
Frequent urination *  4/87 (4.60%)  4 3/89 (3.37%)  3
Worsening renal function (serum creatinine >2.5) *  1/87 (1.15%)  1 0/89 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Cough *  7/87 (8.05%)  7 24/89 (26.97%)  24
Nasal/sinus drainage *  1/87 (1.15%)  1 6/89 (6.74%)  6
Runny nose *  2/87 (2.30%)  2 2/89 (2.25%)  2
Shortness of breath *  0/87 (0.00%)  0 1/89 (1.12%)  1
Wheezing *  0/87 (0.00%)  0 1/89 (1.12%)  1
Hoarseness *  1/87 (1.15%)  1 1/89 (1.12%)  1
Sore throat *  1/87 (1.15%)  1 1/89 (1.12%)  1
Skin and subcutaneous tissue disorders     
Rash *  8/87 (9.20%)  8 1/89 (1.12%)  1
Vascular disorders     
Severe elevation in systolic BP >200 mmHg *  0/87 (0.00%)  0 1/89 (1.12%)  1
*
Indicates events were collected by non-systematic assessment
A limitation of this study is its 1-year study period. Additional limitations include the relatively small sample size, which limited our power to correct for multiple comparisons.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Hajjar
Organization: Emory University
Phone: 404-712-2036
EMail: ihabhajjar@emory.edu
Layout table for additonal information
Responsible Party: Ihab Hajjar, Emory University
ClinicalTrials.gov Identifier: NCT01984164    
Other Study ID Numbers: IRB00070087
R01AG042127 ( U.S. NIH Grant/Contract )
First Submitted: October 27, 2013
First Posted: November 14, 2013
Results First Submitted: December 14, 2020
Results First Posted: February 21, 2021
Last Update Posted: February 21, 2021